Survival Plant-Based

Last updated: April 2, 2025
Sponsor: Danone Global Research & Innovation Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Consumption of a freeze-dried strains-mix.

Clinical Study ID

NCT06768229
23REX0060157
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is to explore the potential of a mix of 4 freeze-dried bifidobacteria strains from Danone collection to survive in human gastro-intestinal (GI) tract of healthy volunteers after 14 days of consumption.

To this aim, one study group of 20 healthy volunteers will consume freeze-dried strains- mix twice per day diluted in 1 glass of still water during 14 consecutive days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-60 years.

  2. Body Mass Index (BMI) between 18.5-30.0 kg/m2.

  3. Willing to consume twice per day for at least 14 days the study product diluted in 1glass of still water.

  4. Availability to comply with the protocol and timetable.

  5. Having regular bowel movements (on ≥6 days/week).

  6. French speaking and reading.

  7. Subject willing to adhere to the specific instructions and restrictions for theentire duration of the study.

  8. Signed (written) informed consent from participant.

  9. Subject is covered by a French health insurance.

  10. Agree to be registered in the national database of subjects participating inclinical research.

  11. Have a smartphone/computer compatible and connectable to internet, and subject iswilling and able to complete the electronic Patient Reported Outcomes (ePRO) usingit.

  12. Women of childbearing potential must be using a medically approved method ofcontraception, or be with a surgically sterile partner or be with a partner of thesame sex.

Exclusion

Exclusion Criteria:

  1. Subject who used within 8 weeks prior to the screening visit or are planning to useduring the conduct of this study one of the listed prohibited medications that mightmodify gastrointestinal function. Incidental use (1 or 2 pills/tablets) ofnon-steroidal anti-inflammatory drugs and aspirin is allowed, if required.

  2. Subject following special diet at the screening visit (V1), or plan for such dietduring the study.

  3. Subject having any previous abdominal surgery, or plan for such surgery during thestudy.

  4. Subject who underwent a general anesthesia in the preceding 4 weeks before thescreening visit (V1).

  5. Subject with any metabolic disease, hypertension, any inflammatory disease, anypsychiatric disorder, or any gastrointestinal disorder, all these medical conditionsshould have been diagnosed by a physician.

  6. Subject with any known food allergy or intolerance to any of the study productcomponents or to any potential traces.

  7. Active smoker with 7 or more cigarettes per week.

  8. Subject doing high intensity physical activity in combination with following anenhanced diet within 1 month before screening or planned during the participation ofthe study.

  9. Subject who underwent dental surgery within the last 4 weeks before the screeningvisit (V1) or plan dental surgery during the course of the study.

  10. Pregnant woman or woman planning to become pregnant during the study orbreastfeeding woman.

  11. Participation in another study with investigational or marketed products potentiallyaffecting the gut microbiota ≤ 4 weeks before the screening visit (V1) or plan forparticipation in any other intervention study during the study.

  12. Employees and/or children/family members or relatives of employees of Danone GlobalResearch & Innovation Center or the participating site.

  13. Subject under guardianship or curatorship.

  14. Excessive alcohol consumption during the past 6 months before the screening visit (V1).

  15. Drug abuse, based on investigator's judgment.

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: Consumption of a freeze-dried strains-mix.
Phase:
Study Start date:
January 09, 2025
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • CEN Experimental

    Dijon, 21000
    France

    Site Not Available

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